Glossary

AJAX progress indicator
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  • Data and Safety Monitoring Board
    A Data and Safety Monitoring Board (DSMB) is an independent group of experts set up to protect patient safety during a clinical trial. This board periodically reviews clinical study data (and they have access to unblinded data in case of blinded studies), incidental event reporting, and(...)
  • Data exclusivity
    Data exclusivity refers to the period during which the data of the original marketing authorisation holder is protected. It is the time during which another company cannot use the originator’s data in support of another marketing authorisation application, i.e.: generics, hybrids, biosimilars.(...)
  • Data Manipulation
    Data manipulation is the process of taking data and manipulating (reformatting) it to be easier to read or better organised. For example, a list of data entries could be organised in alphabetical order, making it easier to view and find information.However, these practices should be used(...)
  • Data Merging
    Data merging is a process that involves combining data from different sources, and providing users with a single view of these data.For example: data from different hospital sites within a clinical trial will be combined for analysis data generated from entirely separate scientific studies(...)
  • Data Monitoring Committee
    Data Monitoring Committee
  • Dear Doctor letter
    Dear Doctor letters are correspondence ― often in the form of a mass mailing from the marketing authorisation holder of a human medicine or biologic ― intended to alert doctors and other healthcare providers about important new or updated information regarding a marketed medicine or(...)
  • Decentralised procedure
    The decentralised procedure is a process for authorising medicines in more than one European Union member state at the same time.
  • Degradants
    Chemical products formed from the breakdown of a medicine due to for example light, temperature, water, reaction with non-active substances, or container and closure systems, etc.
  • Delivery system
    Medicine delivery systems encompass four main related aspects: Routes of delivery (ways in which the medications can be taken, such as orally, by injection, by inhalation, etc.). Delivery vehicles (dosage forms such as pills or slow-release granules). Chemical/biological properties of the(...)
  • Det Nationale Institut for Kommuners og Regioners Analyse og Forskning
    Danish Institute for Local and Regional Government Research http://www.kora.dk/temaer-paa-tvaers/sundhedsoekonomi/"
  • DMC
    Data Monitoring Committee
  • DP
    The decentralised procedure is a process for authorising medicines in more than one European Union member state at the same time.
  • DSMB
    A Data and Safety Monitoring Board (DSMB) is an independent group of experts set up to protect patient safety during a clinical trial. This board periodically reviews clinical study data (and they have access to unblinded data in case of blinded studies), incidental event reporting, and(...)
  • KORA
    Danish Institute for Local and Regional Government Research http://www.kora.dk/temaer-paa-tvaers/sundhedsoekonomi/"

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